Jun 20 2013, 15:59
Gilead Sciencies (GILD) is believed to be leading the hepatitis C pill race, but AbbVie (ABBV) is not far behind. According to Scott Brun, AbbVie's head of pharmaceutical development, AbbVie may even win the race.
In June, at the Goldman Sachs Annual Global Healthcare Conference, he said:
"I'll say that it is a very tight race and like I said we're executing extremely well and I think we've got a very good shot at being first, but it's close."
In a Phase II trial, Gilead's all-oral hepatitis C treatments sofosbuvir and ledipasvir, an NS5A inhibitor, cured 95 percent of patients after eight weeks of the therapy.
Sofosbuvir, which Gilead acquired in 2012 in the famous $11 billion acquisition of Pharmasset, has proved itself in four completed Phase III studies.
In May, following the encouraging interim results from a Phase II trial of sofosbuvir and ledipasvir, Gilead Sciences announced plans for a Phase III trial of a fixed dose of the two drugs. Called ION-3, the study will test a once-daily fixed-dose combination therapy of the two drugs both with and without ribavirin for eight weeks, as well as without ribavirin for 12 weeks. Six hundred non-cirrhotic, new-to-treatment patients with genotype 1 of the virus will participate in the trial.
In June, Gilead received a priority review designation from the FDA, a step that can save about four months in the approval process.
Confident in approval, Gilead is getting ready for the launch of sofosbuvir in the first quarter of 2014 in the U.S. and the second quarter in Europe by preparing sales teams and arranging training opportunities for physicians.
According to Brun, Gilead's advantage is overstated.
AbbVie is running 6 Phase III trials in 30 countries around the world with over 2200 patients.
It is running a dedicated study in cirrhotic patients, who are the hardest to treat of all. Cirrhosis means the liver is scarred, and it functions poorly. Cirrhosis is considered the final stage of chronic liver disease. AbbVie's treatment represents a possible cure, even for these hard-to-treat patients.
AbbVie's HCV portfolio includes experimental medicines with three different mechanisms of action. The compounds in the studies are ABT-450/r (protease inhibitor and ritonavir), ABT-267 (NS5A inhibitor) and ABT-333 (non-nucleoside polymerase inhibitor).
AbbVie's treatment will require three pills in the morning and one at night, according to Brun. In a Phase II trial with the drugs, 90 percent of patients who completed the eight-week regimen had the virus cleared from their body.
Some analysts consider AbbVie's treatment cumbersome compared to Gilead's because it requires four pills a day. But according to Brun, this is a very manageable regimen when you consider the situation of the HIV infected patients who receive Ritonavir (AbbVie's drug for HIV) boosted regimens for a lifetime on a much more complicated schedule. It is a matter of patient education.
AbbVie also is working on next generation programs already: ABT-493 is a protease inhibitor and ABT-530 is an NS5A inhibitor, both with very favorable pharmacologic characteristics, and neither will need Ritonavir boosting.
AbbVie also testing a regimen in Japan for genotype 1b patients requiring two pills once a day for 12 weeks with no Ribavirin. It is using the co-formulation of the ABT-450 and ABT-267 with Ritonavir. This combination is also being prepared for western markets.